Maintenance Engineer

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Maintenance Engineer
Location: Michigan
Pay Rate: Long Term

Job Overview

We are seeking a Maintenance Engineer with 5 8+ years of experience in pharmaceutical maintenance, engineering, equipment qualification, or equipment compliance. The role will support maintenance programs, equipment compliance, risk assessments, GMP documentation, and manufacturing readiness within a regulated pharmaceutical environment.

Key Responsibilities

Review site maintenance programs, preventive maintenance plans, and maintenance frequencies for effectiveness and GMP compliance.
Review executed work orders for completeness, documentation practices, and data integrity.
Perform risk assessments for manufacturing equipment and production lines.
Identify equipment, maintenance, and compliance gaps and associated risks.
Develop processes to confirm equipment is compliant and fit for use before release into manufacturing.
Support equipment qualification and compliance activities.
Review maintenance documentation and identify areas for improvement.
Work with Engineering, Quality, Maintenance, and Manufacturing teams to resolve compliance issues.

Required Qualifications

Bachelor's degree in Engineering or a related field.
5 8+ years of experience in pharmaceutical maintenance, engineering, equipment qualification, or equipment compliance.
Pharmaceutical GMP maintenance or engineering experience.
Experience with sterile injectable or aseptic manufacturing equipment.
Experience with equipment such as washers, tunnels, fillers, cappers, CIP, SIP, parts washers, autoclaves, HVAC, and utilities.
Experience reviewing PM programs, maintenance frequencies, work orders, and maintenance documentation.
Experience performing equipment and process risk assessments.
Strong understanding of GMP documentation and data integrity.
Experience with Maximo or other CMMS platforms is preferred.
Strong troubleshooting and problem-solving skills.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.